Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

Last updated: January 13, 2025
Sponsor: Neurosoft Bioelectronics SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

SOFT ECoG subdural grid electrode

Clinical Study ID

NCT06205160
CIP-01202
  • Ages 18-75
  • All Genders

Study Summary

The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.

Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years at the time of enrolment

  • Lesional epilepsy (incl. mesial temporal sclerosis) that is considered a candidatefor intra-operative high-density grid recordings (incl. patients who underwentstereoelectroencephalography (SEEG) preceding resective surgery)

  • Provided informed consent for study participation by the subject

Exclusion

Exclusion Criteria:

  • Prior brain surgery (excl. SEEG)

  • Occipital lesion

  • Multiple epileptic foci or suspected dual pathology

  • Surgeries involving a disconnection, or hemispherectomy.

  • Planned awake surgery and/or functional recordings

  • Use of anticoagulants that cannot be discontinued during the perioperative period,or a factor XIII deficiency or any other haematological disease

  • Active participation in another investigational device study

  • Any other condition that in the opinion of the investigator may adversely affect thesafety of the subject or would limit the subject's ability to complete the study.

  • Insufficient understanding of Dutch language.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: SOFT ECoG subdural grid electrode
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • University Medical Center (UMC) Utrecht

    Utrecht, 3584CX
    Netherlands

    Active - Recruiting

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